AbbVie looks to expand Vraylar approval, despite mixed data

AbbVie, after announcing mixed results from two phase 3 clinical trials, said it will pursue the expanded use of antipsychotic Vraylar in major depressive disorder.

The oral, once-daily drug, marketed as Vraylar in U.S., is FDA-approved to treat depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia in adults.

AbbVie, looking to expand the treatment's use into major depressive disorder, revealed top-line results from two phase 3 clinical trials, Study 3111-301-001 and Study 3111-302-001. In Study 3111-301-001, Vraylar met its primary endpoint demonstrating statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder.

However, in the second trial, Study 3111-302-001, the drug failed to achieve statistical significance over placebo in depressive symptoms from baseline to week six in MADRS total score.

But, in a previously published phase 2/3 registration-enabling study, the drug managed to beat the placebo. In the RGH-MD-75 study, patients treated with Vraylar flexible doses of 2.0–4.5 mg/day in addition to ongoing antidepressant therapy met the primary endpoint and achieved improved MADRS total scores at week eight compared to placebo.

The positive results of studies 3111-301-001 and RGH-MD-75 appear to be enough for AbbVie to move forward with submitting a supplemental New Drug Application (sNDA) to the FDA for the expanded use of Vraylar for the adjunctive treatment of MDD.